The FDA on Friday approved a plan by the state of Florida to allow direct importation to the state of drugs from Canada, many of which are expected to be at a much lower cost than the same drugs procured in the U.S.
“The FDA may authorize … proposals from states or Indian tribes to import certain prescription drugs from Canada if the [proposal] will significantly reduce the cost to the American consumer without imposing additional risk to public health and safety,” the agency said in a statement. “Florida’s obligations under the FDA’s regulations will include, among other things: ensuring supply chain integrity, monitoring and submitting adverse event reports, complying with drug recall procedures and reporting quarterly to the FDA.”
The proposal, known as a Section 804 importation program, or SIP, “is authorized for 2 years from the date the FDA is notified of the first shipment of drugs to be imported,” according to the agency. The FDA requires the state to:
- Submit additional drug-specific information for the FDA’s review and approval
- Ensure that the drugs Florida seeks to import have been tested for, among other things, authenticity and compliance with the FDA-approved drugs’ specifications and standards
- Relabel the drugs to be consistent with the FDA-approved labeling
- Submit a quarterly report to the FDA that includes information about the imported drugs, cost savings and any potential safety and quality issues
Under Florida’s proposal, the state will start importing prescription drugs “in a small number of drug classes which will include maintenance medications to help individuals who have chronic health conditions such as HIV/AIDS, mental illness, prostate cancer, and urea cycle disorder,” according to a press release issued by the office of Florida Gov. Ron DeSantis (R).
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